A Phase II Clinical Trial of YH23537 in Patients With Chronic Periodontal Disease.

A Double-blind, Randomized, Parallel, Placebo-active Controlled, Multi-center Phase II Clinical Trial to Investigate the Efficacy and Safety of YH23537 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease

This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

at screening visit, at least existing 18 teeth,Mild/moderate/severe periodontitis patients diagnosed with chronic periodontitis according to the CDC / AAP (Center for Disease Control / American Academy for Periodontology) periodontitis classification (2012).

Inclusion Criteria:

• Subjects must be 19 years of age or older
• Have at least 18 natural teeth
• have been diagnosed with chronic periodontitis
• have been diagnosed Mild/Moderate/Severe periodontitis with according to CDC / AAP periodontal classification (2012))
• Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

• Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 4 weeks after the last dose of investigational product.
• Pregnant or lactating females
• Systemic diseases such as diabetes and hypertension
• Patients who take Anticoagulants or Antiplatelet Agents
• Continually use for phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
• Patients who received periodontal treatment within the last 6 months
• Patients who have malignant tumor
• History of positive serologic evidence of current infectious liver disease including HbsAg, or anti-HCV.
• Patients with mental retardation and dementia